A number of researchers have worked to identify a simple and inexpensive method of non-surgical female sterilization. The advantages of a non-surgical sterilization procedure may include easier access to treatment for the patient and increased safety.
One such method that has been developed uses quinacrine pellets, and has been evaluated relative to the two potential advantages noted above. U.S. Pat. No. 4,158,050, the entire contents of which Applicant incorporates herein by reference, discloses the delivery of a solid pellet of quinacrine to the uterine cavity. It is believed that the quinacrine, once located within the uterine cavity, causes fibrosis of the fallopian tubes. Such fibrosis, in turn, prevents pregnancy.
The quinacrine method has shown that a non-surgical method can provide patients with easier access to the treatment, because the delivery of the solid quinacrine pellet is similar to an IUD-insertion, and can be done by para-medical personnel. Sterilization with quinacrine therefore does not require an operating room, and can be done as an outpatient procedure.
While data on quinacrine suggest that it is safer in the short term than surgery, certain researchers have raised issues concerning long-term safety, including the possibility of (1) mutagenicity, (2) carcinogenicity, (3) and increased ectopic pregnancies.
Researchers have also focused their efforts on the treatment of excessive menstrual blood loss and excessive menstrual pain. Excessive menstrual blood loss and pain account for a large number of hysterectomies performed in women in the fourth and fifth decades of life. Management of these conditions in the past has included destruction of the endometrium to induce amenorrhoea. As stated in Ke et al., "Endometrial Ablation to Control Excessive Uterine Bleeding," Human Reproduction, Vol. 6, No. 4, pp. 574-80 (1991), destruction of the endometrium has been attempted cryocoagulation and a variety of other methods. Most of these methods, however, have been abandoned due to a lack of uniformity in the results and potential risks involved.
Currently, endometrial ablation is achieved by surgical procedures. Specifically, laser ablation or electrosurgical resection of the endometrium is performed with the aid of an hysteroscope. These procedures, used for the treatment of excessive menstrual bleeding or menstrual pain, may cause several risks associated with the invasive nature of the surgery. For example, use of the hysteroscope may lead to hemorrhage, absorption of distending media, and accidental perforation of the uterus. Further, these surgical procedures require anesthesia, the use of an operating room, and/or expensive and complex equipment.